The Regulation Of Pharmaceuticals
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The Regulation Of Pharmaceuticals
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Author : Henry G. Grabowski
language : en
Publisher: A E I Press
Release Date : 1983
The Regulation Of Pharmaceuticals written by Henry G. Grabowski and has been published by A E I Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1983 with Law categories.
The authors review the empirical evidence concerning the Food and Drug Administration's effect on the rate of innovation, the delays in introducing new drugs, and the profitability of pharmaceutical research.
Law And The Regulation Of Medicines
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Author : Emily Jackson
language : en
Publisher: Bloomsbury Publishing
Release Date : 2012-03-01
Law And The Regulation Of Medicines written by Emily Jackson and has been published by Bloomsbury Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-03-01 with Law categories.
The principal purpose of this book is to tell the story of a medicine's journey through the regulatory system in the UK, from defining what counts as a medicine, through clinical trials, licensing, pharmacovigilance, marketing and funding. The question of global access to medicines is addressed because of its political importance, and because it offers a particularly stark illustration of the consequences of classifying medicines as a private rather than a public good. Two further specific challenges to the future of medicine's regulation are examined separately: first, pharmacogenetics, or the genetic targeting of medicines to subgroups of patients, and second, the possibility of using medicines to enhance well-being or performance, rather than treat disease. Throughout, the emphasis is on the role of regulation in shaping and influencing the operation of the medicines industry, an issue that is of central importance to the promotion of public health and the fair and equitable distribution of healthcare resources.
International Drug Regulatory Mechanisms
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Author : Albert I. Wertheimer
language : en
Publisher: CRC Press
Release Date : 2022-02-15
International Drug Regulatory Mechanisms written by Albert I. Wertheimer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-02-15 with Medical categories.
Learn how international governments have committed themselves to improving access to quality health care! International Drug Regulatory Mechanisms explores the environment, organization, structure, functioning, and finance of health systems and pharmaceutical markets in 19 countries. Local experts describe each country’s experiences with and lessons learned from the regulation of pharmaceutical products. This book will help government officials, pharmacy educators, and pharmaceutical industry leaders from around the globe identify and develop successful methods for controlling pharmaceutical drug prices and utilization. In International Drug Regulatory Mechanisms, you will learn about the health care system of each country and each government’s measures to control drug costs. This text shows you what government interventions are feasible as well as effective, and the impact of these measures on consumers, government agencies, and the pharmaceutical companies and distributors. Drug policies, reimbursement concepts, and health insurance companies are all examined to give you a better working knowledge of the methodology and guidelines involving drug control in nations such as: Iceland Canada Israel Malaysia Argentina Taiwan Mexico Italy International Drug Regulatory Mechanisms is an extensive text that shows how pharmaceuticals are regulated throughout the world. This book examines how—despite similar goals—price controls, utilization controls, record keeping, and quality requirements differ greatly between countries. Using numerous graphs, tables, and figures, this one-of-a-kind resouce provides you with new insight into which strategies are superior and how to implement these strategies in your own country.
Unhealthy Pharmaceutical Regulation
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Author : C. Davis
language : en
Publisher: Springer
Release Date : 2013-11-08
Unhealthy Pharmaceutical Regulation written by C. Davis and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-11-08 with Medical categories.
This is the first book to examine how effectively American and supranational EU governments have regulated innovative pharmaceuticals during the last 30 years regarding public health. It explains why pharmaceutical regulation has been misdirected by commercial interests and misconceived ideologies.
Science Politics And The Pharmaceutical Industry
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Author : John Abraham
language : en
Publisher: Taylor & Francis
Release Date : 2023-05-31
Science Politics And The Pharmaceutical Industry written by John Abraham and has been published by Taylor & Francis this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-05-31 with Social Science categories.
Drug disasters from Thalidomide to Opren, and other less dramatic cases of drug injury, raise questions about whether the testing and control of medicines provides satisfactory protection for the public. In this revealing study, John Abrahan develops a theoretically challenging realist approach, in order to probe deeply into the work of scientists in the pharmaceutical industry and governmental drug regulatory authorities on both sides of the Atlantic. Through the examination of contemporary controversial case studies, he exposes how the commercial interest of drug manufacturers are consistently given the benefit of the scientific doubts about medicine safety and effectiveness, over and above the best interests of patients.; A highly original combination of philosophical rigour, historical sensitivity and empirical depth enables the "black box" of industrial and government science to be opened up to critical scrutiny much more than in previous social scientific study. All major aspects of drug testing and regulation are considered, including pre- clinical animal tests, clinical trials and postmarketing surveillance of adverse drug reactions. The author argues that drug regulators are too dependent on pharmaceutical industry resources and expertise, and too divorced from public accountability. The problem of corporate bias is particularly severe in the UK, where regulatory decisions about medicine safety are shrouded in greater secrecy than in the US.; Since the purpose of drug regulation should be to maximize the safety and effectiveness of medicines for patients, the public needs and deserves policies to counteract corporate bias in drug testing and evaluation. John Abraham's realist analysis provides a robust basis for policy interventions at the institutional and legislative levels. He proposes that corporate bias could be reduced by more extensive freedom of information, greater autonomy of government scientists from pharmaceutical industry, the development of independent drug testing by the regulatory authority, increased patient representation on regulatory committees, and more frequent and thorough oversight of regulatory performance by the legislature. This book should be of interest to anyone who cares about how medicines should be controlled in modern society. It should prove particularly rewarding for students and researchers in the sociology of science and technology, science and medicines policy, medical sociologists, the medical and pharmaceutical professions, and consumer organizations.
Medical Product Regulatory Affairs
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Author : John J. Tobin
language : en
Publisher: John Wiley & Sons
Release Date : 2011-08-24
Medical Product Regulatory Affairs written by John J. Tobin and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-08-24 with Science categories.
Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
Regulation Of The Pharmaceutical Industry
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Author : J. Abraham
language : en
Publisher: Springer
Release Date : 2003-06-10
Regulation Of The Pharmaceutical Industry written by J. Abraham and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-06-10 with Business & Economics categories.
How are pharmaceutical technologies developed and controlled in our societies? To what extent should the availability of these technologies be determined by scientific experts, a democratic state, the interests of final users, or ethical principles? This unique collection brings together the work of social scientists, ethicists, lawyers and policy analysts on regulation, ethics and innovation in the pharmaceutical industry. Regulatory systems and their implications for public health in North America, Europe and developing countries are discussed, including case studies of norplant, interferon and anti-fertility vaccines.
Regulating Medicines In Europe
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Author : John Abraham
language : en
Publisher: Routledge
Release Date : 2014-04-04
Regulating Medicines In Europe written by John Abraham and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-04-04 with Medical categories.
This Book explains and investigates how medicines are controlled in Europe, especially the EU. Based on penetrating documentary and interview research with the pharmaceutical industry, regulators and consumer organisations,it provides the first major critical examination of the new Europeanised systems of medicine regulation. The authors argue that the drive to produce and approve more drugs more quickly for a single European market dominates other considerations, such as improvements in democratic accountability, the independence of regulators and scientific expertise from commercial interests, and drug safety testing and surveillance.
Regulating Medicines In A Globalized World
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2020-03-25
Regulating Medicines In A Globalized World written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-03-25 with Medical categories.
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Regulation Of Pharmaceuticals In Developing Countries
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Author : D. C. Jayasuriya
language : en
Publisher: World Health Organization
Release Date : 1985-10-01
Regulation Of Pharmaceuticals In Developing Countries written by D. C. Jayasuriya and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 1985-10-01 with Law categories.